Purge Vs no Purge in Living Donor Liver Transplantation Recipients (PNP)

• ClinicalTrials.gov Identifier: NCT02540447
• Recruitment Status: Completed
• First Posted: September 4, 2015
• Results First Posted: October 20, 2015
• Last Update Posted: April 26, 2017
• Sponsor: Mansoura University
• Information provided by (Responsible Party): Amr Mohamed Yassen, Mansoura University

Study Description

Brief Summary:

The investigators tested the impact of purging the graft contents and mesenteric blood into the systemic circulation versus washing out this volume out of the circulation in living donor liver transplantation recipients.

Condition or disease	Intervention/treatment	Phase
Ischemia Reperfusion Injury	Procedure: Purge	Not Applicable

Detailed Description:

All donors had right hepatectomy. On the back table, surgeons flushed liver grafts with 4 Liters of cold Custodiol solution. Patients were randomized into either purge group (Pg) (n=40) were graft fluid contents were washed out by the patient's portal vein blood (0.5ml per gram graft weight) through incompletely anastomosed hepatic vein, or No purge group (NPg) (n=40) where graft fluid contents were washed into the systemic circulation by the patient's portal blood. The primary outcome objective was the mean arterial blood pressure 5 minutes after portal declamping. Secondary objectives included hemodynamic and oxygenation.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Graft Portal Reperfusion Without Purging Graft Preservative Solution In Living Donor Liver Transplantation. A Prospective Randomized Controlled Trial
• Study Start Date: January 2013
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Purge; The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture" that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.	Procedure: Purge; In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping
No Intervention: No Purge; The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.

Outcome Measures

Primary Outcome Measures :

1. Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure [ Time Frame: 5 minutes post-reperfusion ]
   The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping

Secondary Outcome Measures :

1. Biliary Complications (Participants) [ Time Frame: 3 months ]
   Participants who developed biliary complications in three months period (Participant)
2. Ischemia Reperfusion Injury [ Time Frame: 7 days ]
   incidence of ischemia reperfusion injury in the transplanted graft
3. Post-operative Infectious Complications [ Time Frame: 30 days ]
4. 3 Months Mortality [ Time Frame: 3 Months ]
   mortality within first 3 post-operative months

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult living donor liver transplantation recipients of either sex in mansoura liver transplantation program

Exclusion Criteria:

• re-transplantation
• Previous upper abdominal operation
• Budd Chiari syndrome

Contacts and Locations

Locations

Egypt

Liver transplantation project - Gastroenterology surgical center - Mansoura university

Mansoura, Dakahlia, Egypt, 35511

Sponsors and Collaborators

Mansoura University

Investigators

• Principal Investigator: Amr M Yassen, MD; Mansoura Faculty of Medicine

More Information

• Responsible Party: Amr Mohamed Yassen, Professor of Anesthesia and Intensive Care, Mansoura University
• ClinicalTrials.gov Identifier: NCT02540447
• Other Study ID Numbers: Purge_LTX
• First Posted: September 4, 2015
• Results First Posted: October 20, 2015
• Last Update Posted: April 26, 2017
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Amr Mohamed Yassen, Mansoura University:

Liver transplantation; Graft rinse; Ischemia reperfusion injury

Additional relevant MeSH terms:

Reperfusion Injury; Ischemia; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications